This invention relates in general to cellular diseases in human beings and animals and, more particularly, to a method for treatment of certain dermatological conditions of the papulosquamous type wherein a thickening caused by an accumulation and overproduction of epithelial cells occurs, and those conditions of a generally inflammatory nature, or both.
The present invention resides in the administration of diphenoxylate hydrochloride for various cellular afflictions by reason of newly discovered modes of action of said compound. This particular compound and its method of preparation is set forth and described in U.S. Pat. No. 2,898,340 which issued Aug. 4, 1959 and wherein its efficacy in the treatment of diarrhea is noted by reason of its being a highly active inhibitor of gastro-intestinal propulsion and defecation. In about 1960 the combination of diphenoxylate hydrochloride with atropine sulfate was introduced to the market under the trademark LOMOTIL*. This preparation has been only recommended for the symptomatic treatment of diarrhea and gastro-intestinal disorders, being considered effective as adjunctive therapy in the management of diarrhea. Extensive use of this particular combination through the years has proven its safety and efficacy in treating said conditions with a relatively low incidence of adverse reaction. The subtherapeutic dose of atropine sulfate was added to make it practically impossible for extraction of the active principal for purposes of abuse**. The mode of action of diphenoxylate hydrochloride for the aforesaid purpose appears to be through increased intestinal tone and inhibition of gastro-intestinal motility. As indicated, the said compound for such purposes has been taken only systemically and with the unit dose being two tablets, or 5.0 mg. diphenoxylate hydrochloride, four times a day, that is, 20 mg. of diphenoxylate hydrochloride daily. Such dosage level will be required until control of the condition is effected and thereafter the dosage may be reduced for maintenance purposes. FNT *LOMOTIL is a registered trademark of Searle & Co. for tablets containing 2.5 mg. diphenoxylate hydrochloride and 0.025 mg. atropine sulfate, as well as for a liquid wherein each 5 ml. contains the aforesaid amounts of said ingredients. FNT **See Weingarten, B.; Weiss, J., and Simon, M.: "A Clinical Evaluation of a New Antidiarrheal Agent". Amer. Jour. Gastroent. 35:628-33, June 1961.
Accordingly, to the present time, the only utilization of diphenoxylate hydrochloride in human beings has been for diarrhea and gastro-intestinal dysfunctions.
Through extensive study and clinical testing, it has been discovered that certain skin diseases may be treated effectively with diphenoxylate hydrochloride by reason of hitherto unrecognized modes of action of said compound in human beings, as well as in animals. It has been demonstrated most lucidly that when utilized in various dermatological conditions, said compound has the capacity to suppress epithelial proliferation through cytotoxic growth-inhibitory and keratolytic effects on hyperplastic epidermal cells, as well as having anti-pruritic and anti-inflammatory properties. By virtue of these now discovered capacities of the aforesaid compound, the same has demonstrated marked effectiveness in the therapy of certain skin diseases comprehending many which had been to the present time substantially resistant to treatment or for which no specific treatment has been available.
Therefore, it is an object of the present invention to provide a method for treating skin diseases of the papulosquamous and inflammatory types by administering a currently available compound.
It is another object of the present invention to provide a method for the purpose above stated wherein the effective dosage of the particular compound may be administered topically or systemically, or orally, dependent upon the extent of the afflicted areas and desired therapeutic goals.
It is another object of the present invention to provide a method of the character stated which does not cause adverse side reactions upon the patient.
It is a still further object of the present invention to provide a method of the character stated wherein the compound administered is in dosages substantially less than that requisite for use of the compound for its heretofore known and accepted therapeutic purpose.
It is another object of the present invention to provide a method of the character stated which is useful with both adults and children, as well as with animals.
It is a further object of the present invention to provide a method of controlling and/or eliminating itching without respect to the physiologic basis for the same.
It is a still further object of the present invention to provide a method for treating various skin diseases as well as to alleviate symptoms thereof which may be practiced by the patient pursuant to appropriate dosage instructions and thereby obviating the necessity of professional administration.